Coronavirus: Expeditious drug clearances to be given at state level

In a bid to ensure availability of drugs to treat the coronavirus outbreak, which has infected over 100 people in the country, the Centre has expedited environmental clearance for Active Pharmaceutical Ingredients (API) related projects which will get the approval at state level itself.

In a tweet, Union Environment Minister Prakash Javadekar said, "To fast track environment approvals for Active Pharmaceutical Ingredients (APIs) related projects, approval has been accorded for re-categorising E1A in respect of APIs as 'B2' for six months effective till September 30, 2020."
 

He said the decision will help ensure smooth supply of APIs in India.

 

"The decision, which is in line with #EaseofDoingBusiness, will enable project proponents relating to APIs to get Environmental Approvals at State level itself instead of the Centre. This decision has also been taken to prevent any possible disruption in supply of APIs in India," he tweeted.

According to World Health Organisation, API is any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.

Last week, the environment ministry, through a notification, had announced that clearances to bulk drug projects will be expedited by considering them "out of turn".

It had said that expeditious environmental clearances given to units involving active pharmaceutical ingredients (API) and bulk drug intermediates will ensure overall preparedness and availability of drugs to reduce the impact of the outbreak.

"In order to ensure drug availability/production to reduce the impact of the outbreak of Novel Corona virus (COVID-19) and to improve overall preparedness of drugs, the ministry hereby directs projects or activities in respect of Bulk drugs (API and bulk drug intermediates) shall be considered out of turn and clearances shall be issued expeditiously," the notification had said.

The notification was sent to the Central Pollution Control Board, Expert Appraisal Committee and pollution control boards in all states and Union territories.

So far, COVID-19 has claimed three lives and infected 137 persons in India.